Brachytherapy apparatus for asymmetrical body cavities

ABSTRACT

The present disclosure provides a brachytherapy apparatus, system and method that delivers partial breast irradiation treatment for post-lumpectomy patients via introduction of a catheter-like device through a trocar. The apparatus may be introduced post-surgically with local anesthesia under image guidance into the previous excision site and into a cavity by a surgeon. The brachytherapy apparatus includes one or more thin-walled tubes, each of said thin-walled tubes being configured to contain one or more radioactive sources, at least one radiation source configured to deliver a prescribed dose of radiation, a whisk adjuster configured to permit adjustment of each of the one or more thin-walled tubes so that the tubes substantially conform to a size of the body cavity; and an expansion element configured to expand outwardly said one or more thin-walled tubes within the cavity so that the thin-walled tubes substantially conform to a shape and/or size of the body cavity.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/305,437, titled “Brachytherapy Apparatus,” filed on Dec. 16, 2005,with the same inventors as in the present application.

BACKGROUND

1. Field

The present disclosure relates to radiation treatment and moreparticularly, to an apparatus and method that allows cancer patients toreceive a low dose radiation treatment after removal of a tumor.

2. Description of Related Art

Today, a number of treatment options exist for patients who arediagnosed with cancer. With respect to breast cancer, mastectomiescommonly have been used. A mastectomy involves removal of all or a partof the breast tissue, and sometimes also involves removal of theunderlying pectoral muscles and lymph nodes around the breasts.Mastectomies may be accompanied by significant scarring, thus adverselyaffecting the aesthetic appearance or cosmesis of the breast andsurrounding tissue. Moreover, removal of all or large regions of thebreast may have an associated significant physical trauma as well aspsychological trauma.

Various alternative treatment options have been developed to addressadverse affects associated with mastectomies. These alternativetreatment options may involve a breast-sparing lumpectomy. A lumpectomytends to involve removal of only the portion or “lump” of the breastthat contains tissue having tumors. The remaining tissue outside theremoved lump may be treated subsequently with breast irradiation that isdesigned to treat abnormal or suspect tissue that surrounds the removedtumor.

One of the various lumpectomy options involves full breast irradiation.While this option incorporates the breast-sparing lumpectomy, thetreatment time may last for several weeks, with several treatments a dayduring those weeks. At times, the number of treatments may be as much asthirty treatments. Such a high number of treatments may be not onlyinconvenient for the patient, it may also be expensive since each timethe patient sees a doctor, a charge may follow. Even for insuredpatients, all of the charges may not be covered by the patient'sinsurance.

Moreover, lumpectomies involving full breast irradiation may result insignificant surface tissue damage of healthy tissue since the entirebreast is being irradiated. Likewise, the cosmesis or aestheticappearance of the breast may be compromised since the entire breast isbeing irradiated. Moreover, because more tissue is affected, the risk ofcomplications may increase with full breast irradiation.

In order to address the consequences of full breast irradiationprocedures, partial breast irradiation procedures have been developed.These options may incorporate high dose radiation. With high-doseirradiation, significant patient discomfort may result since multipleneedles and catheters are placed into the breast. Moreover, there is agreater chance that surface tissue damage may occur, resulting inscarring and sensitivity due to the use of the multiple needles andcatheters.

Another example of a treatment option that has been developedincorporating partial breast irradiation is one developed by ProximaTherapeutics, Inc., and known as the MAMMOSITE™ radiation therapytreatment system. This system appears to be designed to address some ofthe drawbacks associated with full breast irradiation while alsoaddressing some of the drawbacks associated with high-dose radiation.The procedure involves inflating a balloon so that it fills the emptycavity and inserting a high-dose radiation source for delivery insidethe cavity. The treatment time may be twice a day for five (5) days, fora total of ten (10) treatments. However, the patient selection criteriamay be limited in that patients with small breasts may not be goodcandidates. For example, the breast may be too small to allow properinflation of the balloon since the balloon relies on air for expansion.

Recently, brachytherapy has been used for partial breast irradiation todeliver a more localized treatment of tumor cells after a lumpectomy.Partial breast irradiation is used to supplement surgical resection bytargeting the residual tumor margin after resection, with the goal oftreating any residual cancer in the margin. Radiation therapy can beadministered through one of several methods, or a combination ofmethods, including external-beam radiation, stereotactic radiosurgery,and permanent or temporary interstitial brachytherapy. Owing to theproximity of the radiation source, brachytherapy offers the advantage ofdelivering a more localized dose to the target tissue region.

There is a need for an instrument and associated procedure which can beused to deliver radiation from a radioactive source to target tissuewith a desired intensity and without over-exposure of body tissuesdisposed between the radiation source and the target.

There is further a need for an instrument and associated procedure thathas broad patient selection criteria with reduced office visits.

There is yet further a need for an irradiation procedure that isappropriate not only for breasts, but may be used in treatment regimensfor other areas of the body, such as the brain and prostate.

BRIEF SUMMARY

The present disclosure addresses the deficiencies noted hereinabove byproviding an interstitial brachytherapy apparatus that may be implantedin a single visit, thereby reducing the number of office visits andproviding a more convenient treatment regimen.

In accordance with one embodiment of the present disclosure, abrachytherapy apparatus is provided for delivery of localizedirradiation after surgical tissue removal, where the tissue removalresults in a body cavity surrounded by remaining tissue. The apparatuscomprises one or more thin-walled tubes, each of said thin-walled tubesbeing configured to contain one or more radioactive sources. Theapparatus further comprises at least one radiation source configured todeliver a prescribed dose of radiation, and a whisk adjuster configuredto permit adjustment of each of the one or more thin-walled tubes sothat the tubes substantially conform to a size of the body cavity.Moreover, the apparatus comprises an expansion element configured toexpand outwardly said one or more thin-walled tubes within the cavity sothat the thin-walled tubes substantially conform to a shape and/or sizeof the body cavity.

In accordance with another embodiment of the present disclosure, abrachytherapy apparatus is provided for delivery of localizedirradiation after surgical tissue removal, the tissue removal resultingin a body cavity surrounded by remaining tissue. The apparatus comprisesone or more thin-walled tubes, each of said thin-walled tubes beingconfigured to contain one or more radioactive sources, and at least oneradiation source configured to deliver a prescribed dose of radiation.The apparatus further comprises a whisk adjuster configured to permitadjustment of each of the one or more thin-walled tubes so that thetubes substantially conform to a size of the body cavity, and anexpansion element configured to be engaged to expand outwardly said oneor more thin-walled tubes within the cavity so that the thin-walledtubes substantially conform to a shape and/or size of the body cavity.The apparatus further comprises a center core. After the expansionelement is engaged, the thin-walled tubes are arranged in twosubstantially concentric circles around the center core. The apparatusfurther comprises an opening corresponding to each thin-walled tube, theopening being configured to permit insertion of the at least oneradiation source into each of the one or more thin-walled tubes duringor after surgical implantation of the plurality of thin-walled tubes.

In accordance with still another embodiment of the present disclosure, abrachytherapy system is provided for delivery of localized irradiationafter surgical tissue removal, the tissue removal resulting in a bodycavity surrounded by remaining tissue. The brachytherapy systemcomprises one or more thin-walled tubes, each of said thin-walled tubesbeing configured to contain one or more radioactive sources, and atleast one radiation source configured to deliver a prescribed dose ofradiation. The system further comprises a whisk adjuster configured topermit adjustment of each of the one or more thin-walled tubes so thatthe tubes substantially conform to a size of the body cavity, anexpansion element configured to be engaged to expand outwardly said oneor more thin-walled tubes within the cavity so that the thin-walledtubes substantially conform to a shape and/or size of the body cavity.The system further comprises at least one whisk clip configured tosecure the thin-walled tubes and center core in place to resist a shapeand/or size change of thin-walled tubes when expanded, wherein the atleast one whisk clip includes a locking mechanism.

In yet a further embodiment of the present disclosure, a method isprovided for delivering localized irradiation after surgical tissueremoval, the tissue removal resulting in a body cavity. The methodcomprises creating access to the cavity. The method further comprisesproviding an interstitial brachytherapy apparatus which includes one ormore thin-walled tubes, each of said thin-walled tubes being configuredto contain one or more radiation sources. The apparatus used in themethod further includes at least one radiation source configured todeliver a prescribed dose of radiation, a whisk adjuster configured topermit adjustment of each of the one or more thin-walled tubes so thatthe tubes substantially conform to a size of the body cavity; and anexpansion element configured to expand outwardly said one or morethin-walled tubes within the cavity so that the thin-walled tubessubstantially conform to the shape and/or size of the body cavity. Usingthis apparatus to perform the method, the method further includesplacing the interstitial brachytherapy apparatus into the cavity,expanding outwardly the interstitial brachytherapy apparatus so that itsubstantially conforms to the shape and/or size of the cavity, insertingthe at least one radiation source into the outwardly expandedthin-walled tubes, clamping the interstitial brachytherapy apparatusonto the patient, leaving the interstitial brachytherapy apparatusinside the cavity for a sufficient time to deliver the prescribedradiation dose to remaining tissue that surrounds the cavity; andremoving the interstitial brachytherapy apparatus.

In still yet a further embodiment of the present disclosure, anothermethod is provided for delivering localized irradiation after surgicaltissue removal, the tissue removal resulting in a body cavity. Themethod comprises creating access to the cavity, and providing aninterstitial brachytherapy apparatus that includes one or morethin-walled tubes, each of said thin-walled tubes being configured tocontain one or more radioactive sources. The apparatus further includesat least one radiation source configured to deliver a prescribed dose ofradiation, a whisk adjuster configured to permit adjustment of each ofthe one or more thin-walled tubes so that the tubes substantiallyconform to a size of the body cavity, an expansion element configured tobe engaged to expand outwardly said one or more thin-walled tubes withinthe cavity so that the thin-walled tubes substantially conform to ashape and/or size of the body cavity, a center core; and wherein, afterthe expansion element is engaged, the thin-walled tubes are arranged intwo substantially concentric circles around the center core. Theapparatus further comprises an opening corresponding to each thin-walledtube and/or center core, the opening being configured to permitinsertion of the at least one radiation source into each of the one ormore thin-walled tubes during or after surgical implantation of theplurality of thin-walled tubes. In accordance with the method, thisinterstitial brachytherapy apparatus is placed into the cavity, andexpanded outwardly so that it substantially conforms to the shape and/orsize of the cavity. The method further includes inserting the at leastone radiation source into the outwardly expanded thin-walled tubes,clamping the interstitial brachytherapy apparatus onto the patient,leaving the interstitial brachytherapy apparatus inside the cavity for asufficient time to deliver the prescribed radiation dose to remainingtissue that surrounds the cavity; and removing the interstitialbrachytherapy apparatus.

These, as well as other objects, features and benefits will now becomeclear from a review of the following detailed description ofillustrative embodiments and the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1A is a brachytherapy apparatus in a collapsed state in accordancewith one embodiment of the present disclosure.

FIG. 1B is an embodiment of the apparatus of FIG. 1A in its expandedstate.

FIG. 2 is a breast brachytherapy apparatus having a clamp and in itscollapsed state in accordance with another embodiment of the presentdisclosure.

FIG. 3A is the brachytherapy apparatus of FIG. 2 as it is used in abrachytherapy procedure.

FIG. 3B is the apparatus of FIGS. 2 and 3A in its expanded state inaccordance with one embodiment of the present disclosure.

FIG. 3C is the apparatus of FIG. 3B showing the process of radioactivestrands being placed into the openings.

FIG. 3D is the apparatus of FIG. 3C when the tubes are held tightly inplace.

FIG. 3E is a post-implantation embodiment of the brachytherapy apparatusof FIG. 3D.

FIG. 3F is a post-implantation embodiment of a brachytherapy apparatuswith a post-implantation cap on its end.

FIG. 3G is an embodiment of a brachytherapy apparatus after an obturatorhas been inserted.

FIG. 3H is an embodiment where the tubes are collapsed.

FIG. 3I is an embodiment showing how the brachytherapy apparatus may beremoved from a patient, leaving the suture disk in place temporarily.

FIG. 3J is an illustration of the apparatus having been removed fullyfrom the breast.

FIG. 4A is the brachytherapy apparatus as stacked, substantiallyelliptical, expandable tubes and in a collapsed state in accordance withone embodiment of the present disclosure, and FIG. 4B is the apparatus4A in its expanded state.

FIG. 5 is a single spiral tube strand brachytherapy apparatus inaccordance with another embodiment of the present disclosure.

FIG. 6 is an expandable mesh brachytherapy apparatus in its expandedstate in accordance with yet another embodiment of the presentdisclosure.

FIGS. 7A and 7B illustrate a stent embodiment of a brachytherapyapparatus in a collapsed and expanded state in accordance with still yetanother embodiment of the present disclosure.

FIG. 8 is a multi-tube spiral embodiment of a brachytherapy apparatus inaccordance with still yet another embodiment of the present disclosure.

FIGS. 9A and 9B illustrate a bandoleer-configured brachytherapyapparatus in accordance with still yet another embodiment of the presentdisclosure.

FIG. 10 is an extruded multi-lumen embodiment of a brachytherapy inaccordance with still yet another embodiment of the present disclosure.

FIG. 11 is a bendable tube configuration that includes a sleeveconfigured to slide toward the tubes to reduce the length of the tubesto control the expansion volume.

FIG. 12 is a multi-lumen brachytherapy apparatus having tubes that aresnugly fit from side-to-side.

FIG. 13 is a multi-lumen tube that could also be configured forexpansion at the time of use through the use of molded “knives” at theinterior surface of a sleeve of the apparatus.

FIG. 14A is a side view of a brachytherapy apparatus that includes a capjoined to the tubes.

FIG. 14B is a top view of the cap described in FIG. 14A.

FIG. 14C is a dimensional representation of the cross section of thetubes of FIG. 14A.

FIG. 15 is a dual-sleeved proximal end portion of a brachytherapyapparatus in accordance with one embodiment of the present disclosure.

FIG. 16 is a brachytherapy apparatus having a threaded sleeve and clampin accordance with another embodiment of the present disclosure.

FIG. 17 is the proximal end portion of a brachytherapy apparatus thatincludes a tapered wedge and collet in accordance with anotherembodiment of the present disclosure.

FIG. 18 is the proximal end portion of a brachytherapy apparatus thatincludes clamps for each individual tube as well as a clamp for thecenter tube.

FIG. 19 is the proximal end portion of a brachytherapy apparatus havinga key hole-type toggle mechanism for the center tube.

FIG. 20 is the proximal end of a brachytherapy apparatus having aspiral-type spring mechanism used to hold the lumen in place.

FIG. 21 is the proximal end of a brachytherapy apparatus having a pinmechanism used to hold the lumen in place.

FIG. 22 is another view of a proximal end of a brachytherapy apparatushaving a collet system similar to that shown in FIG. 17.

FIG. 23 is also another view of a proximal end of a brachytherapyapparatus having a collet system similar to that shown in FIG. 17.

FIG. 24 is another view of a proximal end of a brachytherapy apparatushaving a screw mechanism for expanding and collapsing the brachytherapytubes.

FIG. 25 is still another view of a proximal end of a brachytherapyapparatus having a spring mechanism for expanding and collapsing thebrachytherapy tubes.

FIGS. 26A and 26B illustrate an embodiment of a split nut and bumpconfiguration used to hold a center tube in place.

FIGS. 27A and 27B illustrate a brachytherapy apparatus having a ball ofseeds at its end.

FIG. 28A is another embodiment of a brachytherapy apparatus thatincludes supports for the tubes.

FIG. 28B shows the apparatus in a collapsed state.

FIG. 28C shows yet another position for the apparatus inside a cavity.

FIG. 29A is a perspective view of the cutting apparatus.

FIG. 29B a front view of the cutting apparatus with the scissor membersin an open configuration.

FIG. 29C shows the scissor members released.

FIG. 29D shows the scissor members in a locked state.

FIG. 30 is another clamp with cutter in accordance with one embodimentof the present disclosure.

FIG. 31 is a cone clamp in accordance with one embodiment of the presentdisclosure.

FIGS. 32A-32G illustrate an embodiment of a brachytherapy apparatushaving a twist dial expansion apparatus and a gauge to meter the volumeof expansion.

FIG. 33A is an introducer apparatus and other components that may beused to gain access to the post-lumpectomy cavity.

FIG. 33B shows a brachytherapy apparatus, including the sleeve of FIG.33A that was left in the patient, as well as a plurality of thin-walledtubes.

FIG. 33C is a brachytherapy apparatus in accordance with anotherembodiment of the present disclosure.

FIG. 33D is the brachytherapy apparatus of FIG. 33C with a cutter forremoving the portion of the apparatus that is outside of the patient,after implantation of the portion of the brachytherapy apparatus thatincludes the thin-walled tubes used to deliver radiation to the tissuethat remains after the lumpectomy.

FIG. 33E is the brachytherapy apparatus or catheter of FIG. 33D with acap placed on its proximal end.

FIG. 33F is a brachytherapy apparatus with a seed transporter inaccordance with one embodiment of the present disclosure.

FIG. 33G is a brachytherapy catheter and a whisk removal tool inaccordance with one embodiment of the present disclosure.

FIG. 34 is a brachytherapy apparatus having a conformable applicator andtubes configured in two substantially concentric circles in accordancewith another embodiment of the present disclosure.

FIGS. 35A and 35B show a brachytherapy apparatus having tubes that formtwo substantially concentric circles in accordance with yet anotherembodiment of the present disclosure.

FIGS. 35C and 35D show a one-way mechanism that prevents the center corefrom moving in a first direction, and its counterpart release mechanismthat permits movements of the center core in a second direction.

FIG. 36 is an adaptor device designed to facilitate insertion ofradiation sources into the lumen of the center core and/or the tubes ofFIGS. 35A and 35B.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Cancer patients are often diagnosed via an initial biopsy. The treatingsurgeon may then refer the patient to a medical oncologist, who mayassist in determining a treatment regimen and inform the patient ofvarious treatment options. In the case of breast cancer, the canceroustissue is removed via a lumpectomy

While the present disclosure is described in terms of breast cancer, itshould be understood that the apparatus described in the presentdisclosure could also be used as part of a wide variety of othertreatment regimens, including those for prostate cancer, brain cancerand other situations where a cavity is created by removal of a tumor.

The present disclosure provides a brachytherapy apparatus that deliversa low dose, partial breast irradiation treatment for post-lumpectomypatients via introduction of a catheter-like device through a cannula.The device is designed to be introduced post-surgically with localanesthesia under image guidance into the excision site by a surgeon. Forpurposes of the present disclosure, low-dose radiation may be construedas a dosage that would allow a patient to receive a prescribed dose ifthe low-dose radiation source remains in the patient's body over thecourse of 3, 5 or 7 days.

Referring now to FIG. 1A, illustrated is a brachytherapy apparatus 10 ina collapsed state in accordance with one embodiment of the presentdisclosure. As shown, the apparatus 10 includes a plurality of tubes 100at its distal end. The tubes 100 are thin-walled. The wall thickness canbe as small as between 7/1000 of an inch and 12/1000 of an inch. Thetubes 100 are disposed within a sleeve 110. Sleeve could simply bethin-walled heat shrink tubing, and the walls of sleeve could be as thinas 3/1000 of an inch. Each of this plurality of tubes 100 is configuredto contain therein a plurality of low-dose radioactive seed strands. Thetubes have a distal end and a proximal end, and are bundled together atthe distal end and at the proximal end inside sleeve.

The sleeve 110 in which the tubes 100 are disposed is, in turn, passedthrough disk 120. Disk 120 contains a plurality of openings which may beused to suture the apparatus 10 onto a patient so that the apparatus 10may be left in the patient's breast or other body part upon completionof the surgical procedure to insert the apparatus 10. At the proximalend of disk 120, also illustrated is cap 130 which may be used to coverthe cut ends of the tubes 100 when the patient wears the apparatus 10after completion of the surgical procedure for implanting the apparatus10.

When in use, the plurality of tubes 100 of apparatus 10 may be expandedso that the radioactive seeds (not shown) disposed within the tube maybe placed more closely to the tissue within the post-lumpectomy cavity.

Referring now to FIG. 1B, illustrated is an embodiment of the apparatus10 of FIG. 1A in its expanded state. As shown, the apparatus 10 includeseight (8) tubes 100; however, it should be understood that there may bea greater number of tubes or fewer tubes. The number of tubes may bedependent on a number of factors, including but not limited to, the sizeof the cavity into which the apparatus 10 is inserted, the amount ofradiation needed for the patient and the locations in which theradiation is needed. The size of the cavity as well as the amounts andlocations of radiation needed may be determined based on radiationtherapy planning, which may be performed using software specificallydesigned to develop such a radiation plan.

As shown in FIG. 1B, the tubes 100 may expanded to conform to thepost-lumpectomy cavity. The size of the sphere may be largely dependentupon the size of the cavity into which the apparatus 10 is inserted. Inthe embodiment of FIGS. 1A and 1B, the sleeve 110 may be pulled towardthe operator so that the tubes 110 expand. An actuator or center tube140, which extends along the length of the apparatus 10 from its distalend to its proximal end, further assists with expanding and collapsingthe apparatus 10.

Referring now to FIG. 2, illustrated is another embodiment of a breastbrachytherapy apparatus 200 in a collapsed state in accordance with aembodiment of the present disclosure.

As shown in FIG. 2, this embodiment 200 includes a plurality ofsubstantially pie-shaped tubes 205, the proximal ends of which arebundled into a collar 210. Collar 210 is connected to disk 220 throughwhich sutures may be disposed in order to suture the apparatus 200 inplace once it has been positioned within the patient. The apparatusfurther includes a conical piece 240 which assists in expansion and alsomay be used to insert the radioactive seeds, therapeutic elements ordiagnostic elements. The seeds may be separated by one or more spacersto create a radioactive seed strand. Lock screw 235 may be used totighten the center tube 250 and hold the center tube in position withrespect to tubes 205. The obturator also assists in expansion andcollapse of the apparatus 200, when the obturator is held steady and theconical piece 240 is pushed in.

In operation, first, the physician uses a cannula or trocar to enter theoriginal scar site that was created at the time of the original tumorremoval or resection. In the case of the breast, this scar site may haveresulted from a lumpectomy.

Referring now to FIG. 3A, illustrated is the brachytherapy apparatus ofFIG. 2 as it is used in a brachytherapy procedure. In a first step, aphysician may place the apparatus 200 through the original incision site203 of the breast 202 that was originally used to perform thelumpectomy. The tubes 205 may be placed into the cavity 204 of thebreast 202 that remains after the lumpectomy. Disk 220 is kept outsidethe patient's breast 202 so that it may be later sutured onto thepatient. The clamp 230 will assist with expansion and tightening of thetubes 205.

Referring now to FIG. 3B, the apparatus 200 may be expanded much like anumbrella when the physician loosens the lock screw 235, restrains thecentral tube 250 and pushes member 240 in a distal direction. Thesemotions would cause expansion of the plurality of tubes 205 so that thetubes 205 almost fill the cavity 204 of breast 202.

The physician may use visual and other surgical aids to better assessthe position of the tubes 205 inside breast 202. Such aids may bebeneficial since the tubes 205 may not be readily seen once they areinside cavity 204. An ultrasound is one such example of visual orsurgical aid. The ultrasound may be used to detect the position of thetubes 205 in relation to cavity 204. When the tubes are touching thewalls of cavity 204, the physician may see this being illustrated on anultrasound. In some situations, an ultrasound may not be available. Inlieu of—and/or in addition to—using visual or surgical aids, thephysician may use his or her senses to determine when resistance is feltresulting from the tubes 205 pushing against the one or more innersurfaces of cavity 204. Once the tubes are against the inner surfaces ofcavity 204, the physician may tighten the clamp 230 to hold the positionof tubes 205.

Referring now to FIG. 3C, illustrated is the apparatus 200 whereinradioactive seed strands or other therapeutic or diagnostic elements maybe placed into tubes 205 through openings located in conical member 240.The openings are numbered, each number corresponding to one of theplurality of tubes 205. Once the tubes 205 are in position, seed strandsmay be inserted into the tubes via the openings using strand placementtube 270. The openings serve as funnel holes for the tubes.

As mentioned hereinabove, the apparatus of the present disclosure may besuitable for use with common surgical aids. One such surgical aid is aCAT scan which may be used to determine whether the seed strands havebeen accurately positioned in accordance with the radiation therapyplan. As hereinabove mentioned, the radiation therapy plan may becreated with surgical aids such as software designed to form an isodoseprofile. The appropriate isodose profile may call for the seeds to beinserted in a number of ways so as to vary the applied radiation level.For example, in some situations, the isodose profile may not requirethat any seed be inserted into one of the plurality of tubes 205. Insome situations, two or more different seeds used on a single patientmay have different activity levels so that some seeds are stronger thanothers. Low-dose radioactive seeds, e.g., iodine 125 isotope, may beused in conjunction with breast irradiation.

Under some circumstances, the physician may wish to test proper seedinsertion prior to actual insertion by inserting dummy or imitationseeds instead of actual radioactive seeds. This process allows thephysician to avoid potentially damaging the real seeds, yet this processmay be more time-consuming than placing the actual seeds.

Referring now to FIG. 3D, the seed placement tube has been removed andtubes 205 are now held tightly into place with the radioactive seedshaving been placed according to the radiation therapy plan.

Referring now to FIG. 3E, illustrated is a post-implantation embodimentof a brachytherapy apparatus 200 of the present disclosure. As shown,the tubes 205 may be cut leaving disk 220 just outside the breast sothat the sutures may be disposed through openings in disk 220. Thecutting may be performed with a surgical instrument such as a scalpel.Alternatively, the apparatus 200 may be self-cutting using a bladeconfigured to travel across the base of the clamp 230. A cap 280 may beattached to the suture disk to protect the ends of the tubes since thepatient may wear the post-implantation apparatus 200 for several daysbefore treatment ends and the apparatus 200 is removed.

Referring now to FIG. 3F, illustrated is the post-implantationembodiment with a post-implantation cap 280 on its end. It is possiblethat the cap 280 would be secured so that the patient could not removethe cap 280 and disrupt the protocol. At this point, the patient may besent home with a radiopaque shield (e.g., a lead bra) for several days,e.g., 3-5 days.

The apparatus may be removed after a minimum prescribed dose ofradiation has been delivered. As shown in FIG. 3G, the cap 280 has beenremoved and the obturator 260 has been inserted. The clamp 230 wouldneed to be loosened so as to allow the tubes to collapse.

Referring now to FIG. 3H, the tubes 205 are collapsed. The apparatus 200may be removed from the site of insertion 203 or other point deemedappropriate by the physician. Referring now to FIG. 3I, the apparatus200 may be removed from the patient, leaving the suture disk 220 inplace temporarily. Referring now to FIG. 3J, the apparatus 200 has beenremoved fully from the breast.

Referring now to FIG. 4A, illustrated is the brachytherapy apparatus 400as stacked, substantially elliptical, expandable tubes and in acollapsed state in accordance with one embodiment of the presentdisclosure. As illustrated, apparatus 400 includes a plurality ofstacked expanding tubes 410, 420, 430, 440, 450, 460 and 470. Uppermosttube 410 is shown above a number of other tubes including middle tubes430, 440 and lowermost tube 470. The middle tubes 430, 440 have agreater width (w) than uppermost tube 410 and lowermost tube 470.

Referring now to FIG. 4B, illustrated is the apparatus 400 of FIG. 4A inits expanded state. Each tube has a top tube section, a middle tubesection and a lower tube section. As illustrated, connection mechanisms415, 417 connect the top tube section of tube 420 to the bottom tubesection of tube 410. Likewise, connection mechanisms 425, 427 connectthe top tube section of tube 430 to the bottom tube section of tube 420.Connection mechanisms connect the top tube sections of each remainingtube to the bottom tube section of the tube above. However, uppermosttube 410 has no tube above it, and therefore, no connection mechanismsconnect the uppermost tube 410 to the bottom tube section of the aboveit since there is no tube above uppermost tube 410.

Referring now to FIG. 5, illustrated is a single spiral tube strandbrachytherapy apparatus 500 in accordance with another embodiment of thepresent disclosure. As illustrated, a single spiral tube strand is woundaround a spiral tube support 520. Spiral tube support 520 may beconfigured to lengthen so that, when lengthened, the spiral tube strandis elongated and expanded to fill a cavity.

Referring now to FIG. 6, illustrated is an expandable mesh brachytherapyapparatus 600 in its expanded state in accordance with yet anotherembodiment of the present disclosure. As illustrated, the apparatus 600includes a plurality of tubes that are configured in a first direction.For example, tubes 610, 620 and 630 extend diagonally from anorthwesterly direction to a southeasterly direction. A second set oftubes are configured in a second direction. For example, tubes 640, 650and 660 extend from a northeasterly direction to a southwesterlydirection such that tubes 640, 650 and 660 intersect with tubes 610, 620and 630. Radioactive seeds or other therapeutic elements are disposedwithin the plurality of tubes. The diameter of apparatus 600 is greaterin the middle section than in the upper and lower sections.

Referring now to FIG. 7A, illustrated is a stent embodiment of abrachytherapy apparatus 700 in a collapsed state in accordance withstill yet another embodiment of the present disclosure. As illustrated,a plurality of tubes are interconnected to define a conical shape whenthe tube is in its collapsed state.

Referring now to FIG. 7B, illustrated is the stent embodiment of FIG. 7Ain an expanded state. As illustrated the diameter of 700 is greater inthe middle section than in the upper and lower sections.

Referring now to FIG. 8, illustrated is a multi-tube spiral embodimentof a brachytherapy apparatus 800 in accordance with yet anotherembodiment of the present disclosure. As shown, the apparatus 800includes a plurality of tubes that spiral in the same direction. Thetubes are joined at the top and converge near the bottom.

Referring now to FIG. 9A, illustrated is a bandoleer-configuredbrachytherapy apparatus in accordance with still a further embodiment ofthe present disclosure. As illustrated, multiple expandable ribbons withcross tubes attached 910, 920 and 930 are configured to contain aplurality of seeds or other therapeutic elements. The cross tube ribbons910, 920, 930 are threaded through a tube 940 into the cavity. FIG. 9Billustrates how radioactive seeds 922, 924, 926, 928 or othertherapeutic elements may be inserted into the cross tubes 920.

At times, a brachytherapy apparatus may need to be re-sized to fill thecavity that remains after a surgical resection. It may also be desirablethat this re-sizing is performed by the surgeon who is also responsiblefor implanting the brachytherapy apparatus into a patient. It may befurther desirable that the tube bundle be rigid in order to facilitateinsertion.

Referring now to FIG. 10, illustrated is an extruded multi-lumenembodiment of a brachytherapy apparatus 1000 in accordance with yetanother embodiment of the present disclosure. As illustrated, webs 1010hold tubes together in collapsed state, when tube expanded could be slitto the length required so that the tubes may be individually presented.The apparatus 1000 could be manufactured to include the slit webs 1010,and the length of the slits could correspond to the size of a particularsphere 1020 of the apparatus 1000. Alternatively, the surgeon couldperform this slitting process. Moreover, a special cutter could beprovided for the tubes, or the tubes could be marked or gauged todetermine the appropriate length.

Other means may be provided in order to control the length of the tubesin the brachytherapy apparatus so that different cavity sizes areaccommodated. Referring now to FIG. 11, illustrated is a bendable tubeconfiguration that includes a sleeve 1110 configured to slide toward thetubes 1120 to reduce the length of the tubes, thus accommodating smallercavities. The sleeve 1120 may be slid toward disk 1130 to lengthen thetubes 1120, thus accommodating larger cavities. If the tubes 1120 areshortened, it may be desirable to cut any exposed portion of the tubes1120 extending from end section 1140 or sleeve 1110.

A multi-lumen tube could also be configured so that its tubes fitside-to-side when the tube is in its collapsed state. Such an embodimentcould enhance stability of the apparatus. Referring now to FIG. 12,illustrated is a multi-lumen brachytherapy apparatus 1200 having tubesthat are snugly fit from side-to-side.

Referring now to FIG. 13, a multi-lumen tube could also be configuredfor expansion at the time of use through the use of molded “knives” 1310at the interior surface of a sleeve 1320 of the apparatus 1300.

To further facilitate spherical expansion inside the tubes, the tubesmay be molded or welded to a cap. Referring now to FIG. 14A, illustratedis a side view of a brachytherapy apparatus 1400 that includes a cap1410 joined to the tubes 1420. Cap 1410 may be molded or welded to thetubes 1420 in order to facilitate spherical expansion of the tubes 1420.

Referring now to FIG. 14B, illustrated in a top view of the cap 1410described in FIG. 14A. As shown, the cap 1410 has a smooth surface thatcould further facilitate insertion of the apparatus 1400 into the cavityof a patient when in use. Referring now to FIG. 14C, illustrated is adimensional representation of the sphere formed by one of the tubes 1420of FIG. 14A. In order to control the bend radius of the a tube throughwhich the radioactive seeds or other therapeutic elements will pass, thex dimension could be increased or decreased. To gain greater controlover expansion by keeping the tubes equally distributed radially, the ydimension may be adjusted. This sizing will affect the catheter size andthe maximum diameter depending upon the maximum distance between theseeds allowable to maintain the appropriate prescribed dose.

Referring now to FIG. 15 illustrated is a dual-sleeved proximal endportion of a brachytherapy apparatus 1500 in accordance with oneembodiment of the present disclosure. This proximal end portion has twosleeves 1510, 1520 with sleeve 1510 adapted to be slid proximally towarddisk 1530. Accordingly, sleeve 1510 could be slid into, and thusdisposed inside, sleeve 1520 to lengthen any attached tubes, thusaccommodating a larger cavity.

Referring now to FIG. 16, illustrated is a brachytherapy apparatus 1600having a threaded sleeve and clamp in accordance with another embodimentof the present disclosure. As illustrated, the apparatus 1600 includes athreaded sleeve 1610 adapted to receive a plurality of tubes 1605. Thesleeve 1605 protects the tissue against pressure when the tubes 1605need to be opened up. If desired, a physician performing brachytherapycould cut the sleeve to the desired size or the sleeves could bemanufactured to a certain length. At the proximal end of disk 1615, justproximal to clamp 1620, sleeve portion 1625 can be seen as it protrudesfrom clamp 1620. Clamp 1620 squeezes tubes. An obturator is placed intohole of center tube and physically connected to the luer fitting on theend of tube 1640. Lock screw 1650 can be used to hold the center tube inplace. General operation of this apparatus is similar to that shown inFIG. 2.

Referring now to FIG. 17, illustrated is the proximal end portion of abrachytherapy apparatus 1700 that includes a tapered wedge and collet inaccordance with another embodiment of the present disclosure. Thetapered wedge and collet may be used to secure the eight-lumen tube 1710and center tube 1730 to the apparatus. As shown, an eight-lumen tube1710 having webs, such as web 1715, protrudes from sleeve 1720. Centertube 1730 can be seen extending from the middle of the eight-lumen tube1710. Tapered wedge could be inserted on the inside diameter of sleeve1720 to secure the eight-lumen tube 1710. The collet 1750 could be usedto secure the center tube 1730. Once secured, the center tube 1730 wouldbe clamped into place by collet 1750.

Referring now to FIG. 18, illustrated is the proximal end portion of abrachytherapy apparatus 1800 that includes clamps for each individualtube as well as a clamp for the center tube. The center tube 1810 may beclamped by squeezing center tube 1820 using forceps or other devices sothat center tube clamp structure 1815 holds center tube 1810 into place.Each individual clamp may be clamped using individual tube spring member1830 to hold the individual clamp in individual clamp structure 1840.When this spring member 1830 is squeezed, it releases the tube in place.

Referring now to FIG. 19, illustrated is the proximal end portion of abrachytherapy apparatus 1900 having a key hole type toggle mechanism forthe center tube. The key hole-type toggle mechanism 1910 would be turnedin one direction to clamp the center tube in place. The toggle mechanismwould be turned in a second direction to unclamp the center tube.

Referring now to FIG. 20, illustrated is the proximal end of abrachytherapy apparatus 2000 having a spiral-type spring mechanism usedto hold the lumen in place. The spiral-type spring mechanism 2010 couldbe released to collapse the brachytherapy apparatus 2000.

Referring now to FIG. 21, illustrated is the proximal end of abrachytherapy apparatus 2100 having a pin mechanism used to hold thelumen in place. The pin mechanism 2110 could be inserted through a web2130 of the eight-lumen tube 2120 and through the center tube 2140 tohold the center tube in place as well.

Referring now to FIG. 22, illustrated is another view of a proximal endof a brachytherapy apparatus 2200 having a collet system similar to thatshown in FIG. 17. The collet 2210 may be ribbed so that pressure isapplied only to the web of the lumen tube. This would leave the insidediameter undistorted so that the radioactive seeds or strands may passfreely.

Referring now to FIG. 23, illustrated is another view of a proximal endof a brachytherapy apparatus 2200 having a collet system similar to thatshown in FIG. 17. However, in this embodiment, the collet 2310 includesa handle 2320 so that the collet 2310 may be released.

Referring now to FIG. 24, illustrated is yet another view of a proximalend of a brachytherapy apparatus having a screw mechanism for expandingand collapsing the brachytherapy tubes. As shown, between the outer setof tubes 2410 and 2412, the center tube 2414 may be held in place withscrew 2416. When the screw 2416 is turned to move in a distal direction,the center tube 2416 is advanced so that the outer sets of tubes 2410,2412 expand. When the screw 2416 is turned to move in a proximaldirection, the center tube 2416 recedes so that the outer sets of tubes2410, 2412 collapse.

Referring now to FIG. 25, illustrated is still another view of aproximal end of a brachytherapy apparatus having a spring mechanism forexpanding and collapsing the brachytherapy tubes. At one end, the springmechanism 2510 may be attached to cap 2512, while at the other end,spring mechanism 2510 may be attached to suture disk 2514. The springmechanism 2510 may be pulled to expand the tubes 2520. The springmechanism 2510 may be pushed to release the tubes 2520.

Referring now to FIG. 26A, illustrated is a center tube having bumps2610 to facilitate holding the center tube in place. As shown in FIG. 26B, the bumps may fit into a split nut 2620 joined by a handle 2630 tohold the center tube 2640 in place.

Referring now to FIG. 27A, illustrated is a brachytherapy apparatus 2700having a ball of seeds at its end. The apparatus is shown in FIG. 27B isshown as it is inserted into a cavity.

Referring now to FIG. 28A, illustrated is yet another embodiment of abrachytherapy apparatus that includes supports for the tubes. Asillustrated, a cable may be pulled to expand the tubes 2830 disposedinside a cavity. FIG. 28B shows the apparatus 2800 in a collapsed state.FIG. 28C shows yet another position for the apparatus inside a cavity.

FIGS. 29A-29D illustrate a scissor-type clamp apparatus for thethin-walled tubes. FIG. 29A is a perspective view of the apparatus 2900.FIG. 29B is a front view of the apparatus 2900 with the scissor members2910, 2920 in an open configuration. FIG. 29C shows the scissor members2910, 2920 released. FIG. 29D shows the scissor members 2910, 2920 in alocked state.

Referring now to FIG. 30, illustrated is yet another clamp with cutterin accordance with one embodiment of the present disclosure. Asillustrated, the clamp member 3000 includes blades 3010, 3020 that maybe used to cut the thin-walled tubes.

Referring now to FIG. 31, illustrated is a cone clamp 3100 designed foruse in a brachytherapy apparatus in accordance with one embodiment ofthe present disclosure. As illustrated, the cone clamp 3100 is designedto be squeezed and inserted into a conical member 3110, thus holding acenter tube into place. If the center tube is pulled in a distaldirection, the clamp 3100 would be more tightly squeezed. In order torelease the clamp 3100, the clamp 3100 would be squeezed again.

Referring now to FIG. 32A, illustrated is an embodiment of abrachytherapy apparatus 3200 having a twist dial expansion apparatus3210. When the twist dial apparatus 3210 is turned clockwise, a wire orstrip 3220 expands the plurality of tubes 3230 of the apparatus 3200.When the twist dial apparatus is turned in a counterclockwise direction,a wire or strip 3220 may collapse so that the plurality of tubes 3230also collapse.

Referring now to FIG. 32B, illustrated is another view of the twist dialexpansion apparatus 3210. Dial 3240 may be used to expand the apparatus.

Referring now to FIG. 32C, illustrated is a cross-sectional view of thetwist dial expansion apparatus 3210. As shown, a threaded flexible screw3250 may advance when the twist dial expansion apparatus 3240 is turnedto expand the apparatus.

Referring now to FIG. 32D, illustrated is a single twist dial expansionapparatus having multiple tube openings.

Referring now to FIG. 32E, illustrated is a view of the brachytherapyapparatus with openings 3260 and a seed strand 3270 being disposedtherethrough.

Referring now to FIG. 32F, illustrated is the brachytherapy apparatuswith a gauge 3270 to meter the volume of expansion. When the twist dialexpansion apparatus 3240 is turned, the gauge 3270 may show the volumeof expansion.

Referring now to FIG. 32G, illustrates is a gauge 3280 that may be usedin conjunction with a brachytherapy apparatus. The gauge shows thevolume of expansion in terms of cubic centimeters.

The brachytherapy apparatus of the present disclosure may take severalforms. For example, the brachytherapy apparatus may be adjustable by aphysician or other health care practitioner so that it accommodates thesize of an asymmetrical body cavity. For the brachytherapy apparatus ofthe present disclosure, post-lumpectomy patients may be selected basedon the size and shape of their surgical cavity.

The brachytherapy apparatus may be implanted into the patient prior toimplanting the radioactive or therapeutic elements, e.g., radioactiveseeds. In order to begin the implantation process for the brachytherapyapparatus, the physician may administer a local anesthetic to thepatient.

The entry site into the patient may be chosen based on accessconvenience and cavity geometry. Entry to the cavity may be gained in anumber of ways. Referring now to FIG. 33A, illustrated is an introducerapparatus 3300 and other components that may be used to gain access tothe post-lumpectomy cavity. A trocar 3305 which may be, e.g., a 9millimeter trocar, may be inserted into a cavity. Sleeve 3310 may beleft in the patient when the trocar 3305 is withdrawn from the patient,thus creating a conduit to the cavity.

Referring now to FIG. 33B, illustrated is a brachytherapy apparatus3315, including the sleeve 3310 that was left in the patient and aplurality of thin-walled tubes 3320. Brachytherapy apparatus 3315includes a whisk or tube adjuster 3325, a center core clamp 3330 and acenter core 3335. Tube adjuster 3325 may be used to adjust the length ofeach of the plurality of thin-walled tubes 3320 as will be described ingreater detail hereinbelow. Center core clamp 3330 may be used to clampcenter core 3335. Center core 3335 may be used to support the variousthin-walled tubes 3320 and may extend from the distal end near thethin-walled tubes 3320 to the proximal end.

A cutter (not shown) may also be provided to cut sleeve 3310 to a lengththat matches the skin to a cavity distance. The sleeve 3310 may then besutured to the patient via suture disk 3375.

The brachytherapy apparatus or applicator 3315 may be introduced intothe patient through the sleeve 3310 until the distal tip of theapparatus 3315 reaches the far end of the cavity. Using an imagingdevice, e.g., computerized tomography (CT) or an ultrasound which areknown in the art, the physician may expand the distal portion of theapplicator 3315 into a symmetrical “whisk” with twelve (12) tubes. Itshould be understood that the number of tubes may vary depending upon aparticular design and patient's needs.

The physician may expand the tubes 3320 when he/she pulls the centercore 3335 in order to extend outwardly the plurality of thin-walled tubs3320 into a substantially circular configuration around the center core3335 at the distal end. The thin-walled tubes 3320 may be configured intwo substantially concentric circles. If greater length is needed forthe thin-walled tubes 3320 in order to accommodate a larger cavity, thesleeve 3310 may be pulled in a proximal direction in order to create alonger set of tubes. If desired, the physician again may pull the centercore 3335 in a proximal direction to increase the diameter of the twosubstantially concentric circles.

Referring now to FIG. 33C, illustrated is the brachytherapy apparatus ofFIG. 33B in its expanded state. For patients with asymmetrical cavities,the lengths of the individual tubes also may be adjusted to accommodatethe size and/or shape of the cavity. This adjustment action may beaccomplished when the physician pushes one of the raised projections,e.g., 3365 along and within one of the guides, e.g., 3370 to advance theindividual tube, thus lengthening the tube to accommodate the cavity'slarger sections. Each individual tube may have a corresponding raisedprojection as well as a guide.

After confirming the placement of the plurality of thin-walled tubes3320, the physician may lock the tubes 3320 to the sleeve 3310. Thephysician may have determined that the tubes were sufficiently expandedoutwardly based on the pressure and/or resistance he or she feels whenthe brachytherapy apparatus touches the wall of the cavity. It should benoted that sleeve 3310 also has a suture disk 3375 near its proximalend. The suture disk 3375 may be used later to suture the thin-walledtubes 3320 of the brachytherapy apparatus inside a patient. At thispoint, the physician has locked the tubes 3320 to the sleeve 3310 by thetube clip or “whisk clip” 3340.

The physician may use a cutter to remove the portion of the apparatusthat is outside of the patient. Referring now to FIG. 33D, illustratedis the brachytherapy apparatus of Fig, 33C with a cutter 3345 that maybe used for these purposes.

Referring now to FIG. 33E, illustrated is the portion of thebrachytherapy apparatus of FIG. 33D that remains after the tubes havebeen cut. This portion of the apparatus may be referred to as thebrachytherapy catheter 3323 and may include the thin-walled tubes 3320and the center core 3335 that remains after the tubes have been cut. Asshown, the catheter 3323 has appended thereto a cap 3350 at its proximalend. The cap 3350 may be affixed onto the catheter 3323 when the patientis sent home. The catheter 3323 may remain in the cavity, along with itsaccompanying components until the patient returns for further treatmentor the brachytherapy catheter 3323 and accompanying components areremoved.

The patient may be sent home with wound care instructions. The patientmay return to have the radioactive seeds or sources implanted at a laterdate. Before the patient returns, a physician or other health careprofessional may develop a treatment plan based on the image of theexpanded brachytherapy apparatus that includes the plurality ofthin-walled tubes 3320. One or more tubes 3320 may be radiopaque andhave a different color from the others for purposes of identificationduring the imaging process.

The radioactive sources may arrive pre-stranded in a radiation-shieldedseed transporter. Referring now to FIG. 33F, illustrated is abrachytherapy catheter 3323 with a seed transporter 3355 in accordancewith one embodiment of the present disclosure. The seed transporter 3355may have a substantially cylindrical body with an opening 3390 along aside. The physician may engage the seed transporter 3355 to thebrachytherapy catheter 3323 that has been deployed and cut. At theproximal end of seed transport 3355 may be openings 3395 that correspondto each of the thin-walled tubes 3320 of the brachytherapy catheter3323. The physician may then push radioactive stranded seeds into theapparatus 3315 using an obturator (not shown) and an adapter (notshown). The adapter will be described in greater detail hereinbelow.

After the implanted radioactive seeds have been imaged and compared tothe treatment plan, the excess strands—representing the tail end of thethin-walled tubes 3320—outside the apparatus 3320 may be trimmed to ashort length, e.g., ⅛ of an inch, which may allow the physician toremove the strands at a later time. The apparatus 3315 may be recapped,and the patient may be discharged with a radiation shielding bra. Suchbras are known in the art.

The design of the brachytherapy apparatus of the present disclosure maypermit the physician to remove some stranded seeds in the middle of thetreatment period if desired. For example, there may be a need forreducing the dosage of radiation to certain areas of the cavity, e.g.,areas close to the skin or near the chest wall. According to thetreatment plan, the patient may return several days later to have theapparatus 3315 and corresponding seeds removed.

The cap may be removed by the physician, and the stranded seeds may beremoved from the apparatus 3315 by a pair of tweezers (not shown). Thetweezers may be operated from within a shielded container. The physicianmay employ a whisk removal tool in order to remove the apparatus 3315from the patient.

Referring now to FIG. 33G, illustrated is a brachytherapy catheter and awhisk removal tool in accordance with one embodiment of the presentdisclosure. After loosening the whisk clip 3340, the physician maycollapse the whisk by straightening individual thin-walled tubes 3320and attach each of the individual thin-walled tubes to the whisk removaltool 3360. The physician may then remove the apparatus from the patient.

Referring now to FIG. 34, illustrated is a brachytherapy apparatushaving a conformable applicator and tubes configured in twosubstantially concentric circles in accordance with yet anotherembodiment of the present disclosure. This brachytherapy apparatus 3400may be used with both high-dose and low-dose radiation treatments.

The conformable applicator or apparatus includes whisk tubing 3410, acenter core 3420, a whisk expander 3450, a whisk adjuster 3430, andwhisk clips 3440.

The number of thin-walled tubes 3410 in this embodiment is twelve (12).However, as previously noted, the number of tubes may vary according tothe needs and desires of the physician and patient.

The thin-walled tubes 3410 may be arranged into two concentric circlesaround the center core 3420. For example, tube 3412 is interior to tube3413. The distal ends of the thin-walled tubes 3410 and the center core3420 may be joined together, thus allowing the conformable apparatus3400 to be inserted through a small sleeve, e.g., a 9 mm sleeve indiameter, into a body cavity.

The whisk expander 3450 may be used to overcome the initial resistanceto expansion by the plurality of thin-walled tubes 3410. Once activated,the whisk expander 3450 may push the proximal ends of the plurality ofthin-walled tubes 3410 in a distal direction, thereby forcing thethin-walled tubes 3410 to expand into the double-layered whisk as shown.

The whisk adjuster 3430 may permit the physician to change the shape ofthe thin-walled tubes 3410 by moving individual tubes in a distaldirection or, alternatively, in a proximal direction, which may allowthe thin-walled tubes 3410 to conform to shape of a body cavity.

After the whisk adjustment is completed, the whisk clips 3440 may beused to lock the thin-walled tubes 3410 and the center core 3420together in order to resist changing the shape of the thin-walled tubes3410.

The proximal portion of the conformable apparatus 3400 that is at orjust proximal to the whisk clips 3440 may be cut off, thus exposing thelumens of the thin-walled tubes 3410 as well as the center core 3420.One or more radiation sources may then be inserted into the thin-walledtubes 3410.

For high dose rate (HDR) radiation treatment, the radiation source maybe placed in the center core lumen and, if desired, the lumens of theinner layer in the double whisk. After each treatment, the radiationsource may be removed from the patient, but the conformable apparatus3400 may remain in patient until all treatments are completed.

For low dose rate (LDR) radiation treatment, stranded radiation sourcesmay be inserted into the lumens of the double-layered thin-walled tubes3410 that form two substantially concentric circles. These radiationsources may remain in the patient for the duration of treatment. Thepatient may wear a radiation shield to prevent unwanted radiation toother people as well as other undesirable radiation exposure.

At the end of the treatment, the radiation sources may be removed. Awhisk removal tool may be attached to the conformable applicator 3400,and the whisk clips 3440 may be disengaged. After all the plurality ofthin-walled tubes 3410 is straightened by the whisk removal tool, theconformable apparatus 3400 may be pulled out of the patient.

Referring now to FIG. 35A, illustrated is another embodiment of abrachytherapy apparatus having tubes that form two substantiallyconcentric circles. In this embodiment, the brachytherapy apparatus 3500includes a plurality of thin-walled tubes 3510, a center core 3540, awhisk adjuster 3530, and whisk clips 3550.

In accordance with this embodiment and as in the earlier embodiment, theplurality of thin-walled tubes 3510 numbers twelve (12). In the expandedposition as shown, the thin-walled tubes 3510 may be arranged in twoconcentric circles around the center core 3540. The distal ends of theplurality of thin-walled tubes 3510 and the center core 3540 may bejoined, thus allowing the thin-walled tubes 3510 to be inserted througha sleeve 3520 into a body cavity. The sleeve 3520 may be small indiameter, e.g., 9-mm in diameter. The center core 3540 may serve as awhisk expander 3560 and may be used to overcome the straight whisktubing's initial resistance to expansion.

Referring now to FIG. 35B, illustrated is an example of how the whiskmay be expanded. The physician may place a whisk expansion tool 3580 onthe center core 3540 that extends substantially from the proximal end tothe distal end of the apparatus 3500. By gripping the center core 3540with the whisk expansion tool 3580 at the portion just between the whiskadjuster 3530 and the center core end cap 3570, the physician may pullthe center 3540 in a proximal direction, and thereby push thethin-walled tubes 3510 in a distal direction. In this manner, thethin-walled tubes 3510 are forced to expand outwardly into the doublelayered whisk as shown.

The apparatus 3500 may include a one-way mechanism that assists inpreventing the center core 3540 from traveling back in a distaldirection when the whisk expansion tool 3580 is removed. Releasemechanisms 3560, 3562 may also be included for the one-way mechanism sothe center core 3540 can be adjusted back in a distal direction. Theserelease mechanisms 3560, 3562 may be a set of diametrically opposedbuttons configured to be pressed in order to release of the center core3540 so that the center core 3540 may travel in a distal direction.

Referring now to FIG. 35C, illustrated is side view of a one-waymechanism 3575 that assists in preventing the center core from travelingback when the whisk expansion tool is removed. As shown, the one-waymechanism includes jaws 3573 that prevent the center core from travelingback when the whisk expansion tool is removed. Referring now to FIG.35D, illustrated is another view of the one-way mechanism 3575 of FIG.35C. When the release mechanisms 3560, 3562 are engaged, the jaws 3573retract, thus allowing the center core to move in a proximal direction.

Now referring back to FIG. 35B, the whisk adjuster 3530 may permit thephysician to change the shape of the expanded plurality of thin-walledtubes 3510 by moving individual tubes in a distal direction or aproximal direction or a distal direction, thus allowing the expandedtubes 3510 to conform to shape of the body cavity into which they havebeen inserted or implanted.

Once the physician has completed the whisk adjustment, the whisk clips3550 may be used to lock the tubes 3510 and the center core 3540together in place so that the shape of the tubes that have been expandedoutwardly does not change.

The portion of the brachytherapy apparatus that is proximal to the whiskclips 3550 may then be cut off, thus exposing the lumens of the tubes3510 and center core 3540 for insertion of the radiation source orsources.

If high dose rate (HDR) radiation treatment is planned, the radiationsource may be inserted into the lumen of the center core 3540 after thetubes 3510 have been inserted or implanted into the cavity. Moreover, ifdesired, one or more radiation sources may be inserted or implanted intothe lumens of one or more of the tubes 3510 either in lieu of or inaddition to the lumen of the center core 3540.

Referring now to FIG. 36, illustrated is an adaptor device designed tofacilitate insertion of radiation sources into the lumen of the centercore and/or the tubes of FIG. 35A. This HDR adapter is designed tofacilitate the connection of HDR afterloader machines to the thin-walledtubes and/or center core. The HDR afterloader may include a computerthat controls and implements insertion of a radiation source into thecenter core and/or thin-walled tubes of the brachytherapy apparatus.Such afterloader machines are commercially available as VARIAN™,GAMMAMED™ or NUCLETRON™ afterloader machines. The computer may thencontrol how long the radiation source dwells in different portions ofthe cavity based on the isodose profile.

This removable high-dose rate (HDR) adaptor 3600 may be mounted to thebrachytherapy apparatus. The HDR adapter may include thirteen flexibletubes, with the center tube 3610 being configured to connect anafterloader device to the brachytherapy apparatus. The remaining twelveHDR adapter tubes 3612, 3614, 3616, 3618, 3620, 3622, 3624, 3626, 3628,3630, 3632 and 3634 correlate to the twelve (12) tubes of thebrachytherapy apparatus.

After each treatment, the radiation source and the HDR adaptor 3600 mayremoved from the brachytherapy apparatus, but the tubes of brachytherapyapparatus itself may remain in the patient until all treatments arecompleted.

The brachytherapy apparatus and accompanying adapter of FIGS. 35A and36, respectively, may also be used in low dose rate (LDR) radiationtreatment. More particularly, each desired stranded radiation source maybe inserted into the thin-walled tubes and/or center core lumensindividually through an LDR adapter. Alternatively, the strandedradiation sources may be stranded together through a seed transportdevice, which may include both a shielded shipping container and the LDRadapter. The LDR adapter or the transfer device may be removed after theLDR radiation sources are inserted into the thin-walled tubes and/orcenter core lumen. Since the LDR radiation sources may remain in thepatient for as long as it takes to deliver a prescribed dose ofradiation, the patient may need to wear a radiation shield to preventunwanted radiation exposure. At the end of the treatment, the radiationsources may be removed, regardless of whether HDR radiation sources orLDR radiation sources are used.

While the specification describes particular embodiments of the presentinvention, those of ordinary skill can devise variations of the presentinvention without departing from the inventive concept.

1. A brachytherapy apparatus for delivery of localized irradiation aftersurgical tissue removal, the tissue removal resulting in a body cavitysurrounded by remaining tissue, the apparatus comprising: one or morethin-walled tubes, each of said thin-walled tubes being configured tocontain one or more radioactive sources; at least one radiation sourceconfigured to deliver a prescribed dose of radiation; a whisk adjusterconfigured to permit adjustment of each of the one or more thin-walledtubes so that the tubes substantially conform to a size of the bodycavity; and an expansion element configured to expand outwardly said oneor more thin-walled tubes within the cavity so that the thin-walledtubes substantially conform to a shape and/or size of the body cavity.2. The brachytherapy apparatus of claim 1, further comprising: anopening corresponding to each of the one or more thin-walled tubes, theopening being configured to permit insertion of the at least oneradiation source into each of the one or more thin-walled tubes duringor after surgical implantation of the plurality of thin-walled tubes. 3.The brachytherapy apparatus of claim 1, wherein the whisk adjusterincludes: a raised projection and a guide corresponding to each of theone or more thin-walled tubes, each raised projection being configuredto be moved within the guide to adjust the length of the correspondingthin-walled tube.
 4. The brachytherapy apparatus of claim 1, furthercomprising: a sleeve disposed around the plurality of thin-walled tubes,the sleeve being configured to move either in a proximal direction or ina distal direction to accommodate the size of the cavity.
 5. Thebrachytherapy apparatus of claim 4, wherein the sleeve is furtherconfigured to receive a trocar therethrough in order to permit entry ofthe apparatus into the cavity site.
 6. The brachytherapy apparatus ofclaim 1, wherein the expansion element is a center core configured to bepulled in a proximal direction.
 7. The brachytherapy apparatus of claim1, wherein the center core is configured to be gripped and pulled in theproximal direction by a whisk expansion tool.
 8. The brachytherapyapparatus of claim 1, further comprising: a one-way mechanism configuredto prevent movement of the center core in a distal direction.
 9. Thebrachytherapy apparatus of claim 8, further comprising: a releasemechanism configured to permit movement of the center core in the distaldirection.
 10. The brachytherapy apparatus of claim 9, wherein therelease mechanism includes two diametrically opposed buttons positionedon the exterior of the whisk adjuster, and wherein the buttons areconfigured to be pushed, thus permitting movement of the center core inthe distal direction.
 11. The brachytherapy apparatus of claim 1,further comprising: at least one whisk clip configured to secure thethin-walled tubes and center core in place to resist a shape and/or sizechange of thin-walled tubes when expanded.
 12. The brachytherapyapparatus of claim 1, wherein the expansion element includes a handleconfigured to be gripped in order to expand outwardly the plurality ofthin-walled tubes.
 13. A brachytherapy apparatus for delivery oflocalized irradiation after surgical tissue removal, the tissue removalresulting in a body cavity surrounded by remaining tissue, the apparatuscomprising: one or more thin-walled tubes, each of said thin-walledtubes being configured to contain one or more radioactive sources; atleast one radiation source configured to deliver a prescribed dose ofradiation; a whisk adjuster configured to permit adjustment of each ofthe one or more thin-walled tubes so that the tubes substantiallyconform to a size of the body cavity; an expansion element configured tobe engaged to expand outwardly said one or more thin-walled tubes withinthe cavity so that the thin-walled tubes substantially conform to ashape and/or size of the body cavity; a center core; and wherein, afterthe expansion element is engaged, the thin-walled tubes are arranged intwo substantially concentric circles around the center core; and anopening corresponding to each thin-walled tube, the opening beingconfigured to permit insertion of the at least one radiation source intoeach of the one or more thin-walled tubes during or after surgicalimplantation of the plurality of thin-walled tubes.
 14. Thebrachytherapy apparatus of claim 13, wherein the whisk adjusterincludes: a raised projection and a guide corresponding to each of theone or more thin-walled tubes, each raised projection being configuredto be moved within the guide to adjust the length of the correspondingthin-walled tube.
 15. The brachytherapy apparatus of claim 13, furthercomprising: a sleeve disposed around the plurality of thin-walled tubes,the sleeve being configured to move in either a proximal direction or adistal direction to accommodate the shape and/or the size of the cavity.16. The brachytherapy apparatus of claim 15, wherein the sleeve isfurther configured to receive a trocar therethrough in order to permitentry to the cavity site.
 17. The brachytherapy apparatus of claim 13,wherein the expansion element is the center core, and said center coreis configured to be pulled in a proximal direction.
 18. Thebrachytherapy apparatus of claim 13, wherein the center core isconfigured to be gripped and pulled in the proximal direction by a whiskexpansion tool.
 19. The brachytherapy apparatus of claim 13, furthercomprising: a one-way mechanism configured to prevent movement of thecenter core in a distal direction.
 20. The brachytherapy apparatus ofclaim 19, further comprising: a release mechanism configured to permitmovement of the center core in the distal direction.
 21. Thebrachytherapy apparatus of claim 20, wherein the release mechanismincludes two diametrically opposed buttons on the exterior of the whiskadjuster, and wherein the buttons are configured to be pushed, thuspermitting movement of the center core in the distal direction.
 22. Thebrachytherapy apparatus of claim 13, further comprising: at least onewhisk clip configured to secure the thin-walled tubes and center core inplace to resist a shape and/or size change of thin-walled tubes whenexpanded.
 23. The brachytherapy apparatus of claim 13, wherein theexpansion element includes a handle configured to be gripped in order toexpand outwardly the plurality of thin-walled tubes.
 24. A brachytherapysystem for delivery of localized irradiation after surgical tissueremoval, the tissue removal resulting in a body cavity surrounded byremaining tissue, the system comprising: one or more thin-walled tubes,each of said thin-walled tubes being configured to contain one or moreradioactive sources; at least one radiation source configured to delivera prescribed dose of radiation; a whisk adjuster configured to permitadjustment of each of the one or more thin-walled tubes so that thetubes substantially conform to a size of the body cavity; an expansionelement configured to be engaged to expand outwardly said one or morethin-walled tubes within the cavity so that the thin-walled tubessubstantially conform to a shape and/or size of the body cavity; and atleast one whisk clip configured to secure the thin-walled tubes andcenter core in place to resist a shape and/or size change of thin-walledtubes when expanded, wherein the at least one whisk clip includes alocking mechanism.
 25. The brachytherapy system of claim 24, furthercomprising: a cutting apparatus configured to cut the thin-walled tubesso as to remove excess tube length that remains beyond the proximal endof the at least one whisk clip after a cavity size and/or shape has beenaccommodated.
 26. The brachytherapy system of claim 24, furthercomprising: a center core; and wherein, after the expansion element isengaged, the thin-walled tubes are arranged in two substantiallyconcentric circles around the center core.
 27. The brachytherapy systemof claim 26, further comprising: a seed transport device configured tofacilitate insertion of radioactive sources into the thin-walled tubesand/or the center core.
 28. The brachytherapy system of claim 27,wherein the seed transport device includes: a substantially cylindricalbody having a distal end and a proximal end, and an obturator cavitydisposed at the distal end; wherein the distal end of the seed transportdevice is configured to engage with the locking mechanism of the atleast one whisk clip, wherein the proximal end of the seed transportdevice includes openings corresponding to each of the plurality ofthin-walled tubes and the center core in order to permit one or moreradiation sources to be inserted through the openings; and wherein theobturator cavity is configured to permit an obturator to be storedtherein, the obturator being capable of inserting one or more radiationsources into the thin-walled tubes and center core.
 29. Thebrachytherapy system of claim 24, wherein the radiation source is a highdose rate radiation source, and the system further comprises: a highdose rate adapter configured to permit a computer-based afterloadermachine to insert the at least one high dose rate radiation source intothe one or more thin-walled tubes and/or a center core, and wherein thehigh dose rate adapter is further configured to permit thecomputer-based afterloader machine to control the movement of the atleast one high dose rate radiation source within the body cavity. 30.The brachytherapy system of claim 29, wherein the high dose rate adapterincludes: a plurality of substantially flexible tubes, the substantiallyflexible tubes corresponding to each of the plurality of thin-walledtubes and the center core; an opening at the distal end of eachsubstantially flexible tube.
 31. The brachytherapy system of claim 24,further comprising: a whisk removal tool configured to remove abrachytherapy catheter after treatment is complete.
 32. A method fordelivering localized irradiation after surgical tissue removal, thetissue removal resulting in a body cavity, the method comprising:creating access to the cavity; providing an interstitial brachytherapyapparatus, comprising: one or more thin-walled tubes, each of saidthin-walled tubes being configured to contain one or more radiationsources; at least one radiation source configured to deliver aprescribed dose of radiation; a whisk adjuster configured to permitadjustment of each of the one or more thin-walled tubes so that thetubes substantially conform to a size of the body cavity; and anexpansion element configured to expand outwardly said one or morethin-walled tubes within the cavity so that the thin-walled tubessubstantially conform to the shape and/or size of the body cavity;placing the interstitial brachytherapy apparatus into the cavity;expanding outwardly the interstitial brachytherapy apparatus so that itsubstantially conforms to the shape and/or size of the cavity; insertingthe at least one radiation source into the outwardly expandedthin-walled tubes; clamping the interstitial brachytherapy apparatusonto the patient; leaving the interstitial brachytherapy apparatusinside the cavity for a sufficient time to deliver the prescribedradiation dose to remaining tissue that surrounds the cavity; andremoving the interstitial brachytherapy apparatus.
 33. A method fordelivering localized irradiation after surgical tissue removal, thetissue removal resulting in a cavity, the method comprising: creatingaccess to the cavity; providing an interstitial brachytherapy apparatus,comprising: one or more thin-walled tubes, each of said thin-walledtubes being configured to contain one or more radioactive sources; atleast one radiation source configured to deliver a prescribed dose ofradiation; a whisk adjuster configured to permit adjustment of each ofthe one or more thin-walled tubes so that the tubes substantiallyconform to a size of the body cavity; an expansion element configured tobe engaged to expand outwardly said one or more thin-walled tubes withinthe cavity so that the thin-walled tubes substantially conform to ashape and/or size of the body cavity; a center core; and wherein, afterthe expansion element is engaged, the thin-walled tubes are arranged intwo substantially concentric circles around the center core; and anopening corresponding to each thin-walled tube, the opening beingconfigured to permit insertion of the at least one radiation source intoeach of the one or more thin-walled tubes and/or center core during orafter surgical implantation of the plurality of thin-walled tubes.placing the interstitial brachytherapy apparatus into the cavity;expanding outwardly the interstitial brachytherapy apparatus so that itsubstantially conforms to the shape and/or size of the cavity; insertingthe at least one radiation source into the outwardly expandedthin-walled tubes and/or center core; clamping the interstitialbrachytherapy apparatus onto the patient; leaving the interstitialbrachytherapy apparatus inside the cavity for a sufficient time todeliver the prescribed radiation dose to remaining tissue that surroundsthe cavity; and removing the interstitial brachytherapy apparatus.